A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age
NCT ID: NCT06740630
Last Updated: 2025-03-07
Study Results
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Basic Information
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RECRUITING
PHASE3
1840 participants
INTERVENTIONAL
2025-01-10
2027-05-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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VNS_Lot 1 Group
Participants receive 1 dose of the investigational VNS vaccine of Lot 1, 1 dose of measles, mumps, and rubella (MMR) vaccine, 1 dose of hepatitis A vaccine (HAV), and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
Investigational varicella vaccine_Lot 1
Investigational varicella vaccine of Lot 1 administered subcutaneously.
MMR vaccine
MMR vaccine co-administered subcutaneously or intramuscularly.
Hepatitis A vaccine
Hepatitis A vaccine co-administered intramuscularly.
PCV (pneumococcal conjugate vaccine) 13
The 13-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
PCV 20
The 20-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
Vaxneuvance
The Vaxneuvance (15-valent pneumococcal conjugate vaccine) co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
VNS_Lot 2 Group
Participants receive 1 dose of the investigational VNS vaccine of Lot 2, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
Investigational varicella vaccine_Lot 2
Investigational varicella vaccine of Lot 2 administered subcutaneously.
MMR vaccine
MMR vaccine co-administered subcutaneously or intramuscularly.
Hepatitis A vaccine
Hepatitis A vaccine co-administered intramuscularly.
PCV (pneumococcal conjugate vaccine) 13
The 13-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
PCV 20
The 20-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
Vaxneuvance
The Vaxneuvance (15-valent pneumococcal conjugate vaccine) co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
VNS_Lot 3 Group
Participants receive 1 dose of the investigational VNS vaccine of Lot 3, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
Investigational varicella vaccine_Lot 3
Investigational varicella vaccine of Lot 3 administered subcutaneously.
MMR vaccine
MMR vaccine co-administered subcutaneously or intramuscularly.
Hepatitis A vaccine
Hepatitis A vaccine co-administered intramuscularly.
PCV (pneumococcal conjugate vaccine) 13
The 13-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
PCV 20
The 20-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
Vaxneuvance
The Vaxneuvance (15-valent pneumococcal conjugate vaccine) co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
VV_Lot 1 Group
Participants receive 1 dose of a marketed varicella vaccine (VV) of Lot 1, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
Marketed varicella vaccine_Lot 1
Marketed varicella vaccine of Lot 1 administered subcutaneously.
MMR vaccine
MMR vaccine co-administered subcutaneously or intramuscularly.
Hepatitis A vaccine
Hepatitis A vaccine co-administered intramuscularly.
PCV (pneumococcal conjugate vaccine) 13
The 13-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
PCV 20
The 20-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
Vaxneuvance
The Vaxneuvance (15-valent pneumococcal conjugate vaccine) co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
VV_Lot 2 Group
Participants receive 1 dose of a marketed VV of Lot 2, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
Marketed varicella vaccine_Lot 2
Marketed varicella vaccine of Lot 2 administered subcutaneously.
MMR vaccine
MMR vaccine co-administered subcutaneously or intramuscularly.
Hepatitis A vaccine
Hepatitis A vaccine co-administered intramuscularly.
PCV (pneumococcal conjugate vaccine) 13
The 13-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
PCV 20
The 20-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
Vaxneuvance
The Vaxneuvance (15-valent pneumococcal conjugate vaccine) co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
Interventions
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Investigational varicella vaccine_Lot 1
Investigational varicella vaccine of Lot 1 administered subcutaneously.
Investigational varicella vaccine_Lot 2
Investigational varicella vaccine of Lot 2 administered subcutaneously.
Investigational varicella vaccine_Lot 3
Investigational varicella vaccine of Lot 3 administered subcutaneously.
Marketed varicella vaccine_Lot 1
Marketed varicella vaccine of Lot 1 administered subcutaneously.
Marketed varicella vaccine_Lot 2
Marketed varicella vaccine of Lot 2 administered subcutaneously.
MMR vaccine
MMR vaccine co-administered subcutaneously or intramuscularly.
Hepatitis A vaccine
Hepatitis A vaccine co-administered intramuscularly.
PCV (pneumococcal conjugate vaccine) 13
The 13-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
PCV 20
The 20-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
Vaxneuvance
The Vaxneuvance (15-valent pneumococcal conjugate vaccine) co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
Eligibility Criteria
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Inclusion Criteria
* Written or witnessed/thumb printed informed consent obtained from the participant's parent(s)/LAR(s) prior to performance of any study-specific procedure.
* Healthy participants as established by medical history and clinical examination before entering into the study.
* A male or female between, and including, 12 to 15 months of age (i.e., from the day of 1-year birthday until the day before 16 months of age) at the time of the administration of study interventions.
* Only for children in countries where PCV is recommended at 12 to 15 months of age as per national immunization schedule and provided as part of the study interventions:
* Participant who previously received the primary series of PCV in the first year of life with last dose at least 60 days prior to study entry.
Exclusion Criteria
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Hypersensitivity to latex.
* Major congenital defects, as assessed by the investigator.
* Recurrent history of uncontrolled neurological disorders or seizures.
* History of varicella disease.
* Active untreated tuberculosis.
* Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
* Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study interventions during the period beginning 30 days before the dose of study interventions administration (Day -29 to Day 1), or their planned use during the study period.
* Planned administration of a vaccine in the period starting 30 days before the dose and ending 43 days after the dose of study interventions administration\* (Visit 2) with the exception of inactivated influenza vaccine which may be given at any time during the study and administered at a different location than the study interventions.
Any other age-appropriate vaccine may be given starting at Visit 2 and anytime thereafter.
\*If emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is organized by public health authorities outside the routine immunization program, the time period described above can be reduced provided it is used according to the local governmental recommendations and sponsor is notified
* Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune modifying treatments at any time up to the end of the study.
* Up to 90 days prior to the study intervention administration:
* For corticosteroids, this will mean prednisone equivalent \>=0.5 mg/kg/day with maximum of 20 mg/day for pediatric participants. Inhaled and topical steroids are allowed.
* Administration of immunoglobulins and/or any blood products or plasma derivatives.
* Up to 180 days prior to study interventions administration: long acting immune-modifying drugs including among others immunotherapy (e.g., tumor necrosis factor-inhibitors), monoclonal antibodies (except the ones not interfering with the immune response to the study vaccines, e.g., nirsevimab), antitumoral medication.
* Previous vaccination against measles, mumps, and rubella.
* Previous vaccination against hepatitis A virus.
* Previous vaccination against varicella virus.
* Only for children in countries where PCV is recommended at 12 to 15 months of age as per national immunization schedule and provided as part of the study interventions, participant who previously received a booster dose of any PCV.
* Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device).
* Child in care.
* Any study personnel's immediate dependents, family, or household members.
* Participants with the following high-risk individuals in their household:
* Immunocompromised individuals.
* Pregnant women without documented history of varicella.
* Newborn infants of mothers without documented history of varicella.
* Newborn infants born less than (\<) 28 weeks of gestation.
12 Months
15 Months
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Locations
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GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
Bingham Farms, Michigan, United States
GSK Investigational Site
McAllen, Texas, United States
GSK Investigational Site
Layton, Utah, United States
GSK Investigational Site
Layton, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-515869-33-00
Identifier Type: OTHER
Identifier Source: secondary_id
213998
Identifier Type: -
Identifier Source: org_study_id
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